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RegisterStudy termination [Regulatives / Guidelines]
Dear All
Please give your views in the following case:
If in period-1 of bio-study, out of 36 subjects, 13 subjects withdrawn due to Pharmacokinetic reasons (due to AE of vomiting) but not any serious safety issues;
Please give your views in the following case:
If in period-1 of bio-study, out of 36 subjects, 13 subjects withdrawn due to Pharmacokinetic reasons (due to AE of vomiting) but not any serious safety issues;
- If power of study reduces to very large extent, study will not pass as per regulatory requirement.Would it be ethical to conduct second period?
- If study is to be terminated, is it required to submit termination report to DCGI? And if study for US regulatory, is it required to submit termination report to USFDA?
Complete thread:
- Study terminationanky1212 2013-05-08 18:18
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Study termination Helmut 2013-05-08 22:12
- Study termination anky1212 2013-05-09 13:17
- Study termination drgunasakaran1 2013-05-09 19:59
- Study termination Helmut 2013-05-08 22:12
Ing. Helmut Schütz